Placental Risk Assessment to CusTomize Individualized Pregnancy Care and Evaluation

NCT ID: NCT07144839

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

640 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-09-18

Study Completion Date

2029-06-30

Brief Summary

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This is a prospective observational study with the goal of developing and assessing a predictive model of placental insufficiency.

Detailed Description

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Pregnant study participants will be recruited and monitored throughout pregnancy with ultrasound and blood draws, and delivery and neonatal data up to 28 days following birth. This data will be used to develop a model to predict placental insufficiency.

Conditions

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Stillbirth Placental Insufficiency

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Observational Cohort

Pregnant people age 15 and older, without known major fetal anatomic or genetic abnormalities, singleton gestation will be monitored via ultrasound and blood tests throughout pregnancy. Delivery data and neonatal outcomes will be collected. Data will be used to develop a predictive model of placental insufficiency.

Data Collection Throughout Pregnancy and Delivery

Intervention Type OTHER

Participants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected.

Interventions

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Data Collection Throughout Pregnancy and Delivery

Participants will receive monitoring by ultrasound and blood tests at three time points during pregnancy, and delivery and neonatal data will be collected.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Pregnant
* Age 15 or older
* No known major fetal anatomic or genetic abnormalities
* Singleton gestation
* Planning to deliver at Oregon Health \& Science University
* Prior to 22 weeks' gestation

Exclusion Criteria

* Decisional impairment
* Multiple gestation
* Known fetal growth restriction or major congenital anomaly
* Inability to consent
* Inability to attend study visits
Minimum Eligible Age

15 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

NIH

Sponsor Role collaborator

Oregon Health and Science University

OTHER

Sponsor Role lead

Responsible Party

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Karen Gibbins

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Karen Gibbins

Role: PRINCIPAL_INVESTIGATOR

Oregon Health and Science University

Locations

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Oregon Health & Science University

Portland, Oregon, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Women's Health Research Unit Department of Ob/Gyn

Role: CONTACT

503-494-3666

Facility Contacts

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Women's Health Research Unit

Role: primary

503-494-3666

Other Identifiers

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1R01HD115604-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

STUDY00026808

Identifier Type: -

Identifier Source: org_study_id